Global Pharmacovigilance QA Auditor

Johnson & Johnson Innovative Medicine; Petaling Jaya; On-site; MYR 60,000 - 90,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Pharmacovigilance Auditor to lead PV audits and support regulatory inspections in a global setting. The role emphasizes PV operations, QA auditing, and cross-functional cooperation across geographies.

The ideal candidate has 2+ years in PV and PV/GVP auditing, strong analytical skills, and the ability to work with multiple teams. This position focuses on quality, safety, and risk management within a fast-paced environment.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline.
• Minimum 2 years of experience in Pharmacovigilance (PV) within the pharmaceutical or biotech industry.
• 2+ years of QA auditing experience, specifically in PV/GVP audits preferred.
• Experience auditing PV systems, processes, databases, and service providers preferred.

Responsibilities

• Leads planning, conduct and reporting of PV audits and supports non-routine audits to ensure compliance.
• Supports regulatory inspections in various roles as needed.
• Completes required training for inspection readiness and may help prepare training material.
• Participates in projects and ensures milestones and timelines are met.
• Provides consultation to business partners on routine tasks and handles non-routine issues.

Skills

Analytical thinking

Attention to detail

Communication skills

Cross-functional collaboration

Global / geographies

Education

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline

Job description

Johnson & Johnson Innovative Medicine is seeking a Pharmacovigilance Auditor to lead PV audits and support regulatory inspections in a global setting. The role emphasizes PV operations, QA auditing, and cross-functional cooperation across geographies.

The ideal candidate has 2+ years in PV and PV/GVP auditing, strong analytical skills, and the ability to work with multiple teams. This position focuses on quality, safety, and risk management within a fast-paced environment.